RX-360 - Key Persons
Job Titles:
- Manager, Member Engagement
- Manager, Membership Engagement
Job Titles:
- Member of the Board of Directors
- Director, External Supply Quality, Amgen
Job Titles:
- Member of the Board of Directors
- Expert
- Quality Assurance Executive
- VP, Enterprise Regulatory Compliance, Johnson and Johnson
Anthony Damas is a quality assurance executive and compliance subject matter expert, with experience leading teams in global regulatory environments. Currently, he is the Vice President, Enterprise Regulatory Compliance at Johnson & Johnson. In this role, he partners with senior leaders to provide strategy and framework to ensure a strong regulatory compliance profile. Anthony joined Johnson & Johnson in 2021 and leads the Enterprise Independent Audit and External Manufacturer/Supplier Audit program, Strategic Compliance Operations, Compliance Policy Management, the Office of Special Investigations, and Enterprise Design Assurance. Prior to joining Johnson and Johnson, Anthony held several positions with Medtronic, Stryker, TE Connectivity Medical, and Acumed LLC in various leadership, quality and project management functions.
Anthony has his Bachelor of Science in Mechanical Engineering from Rensselaer Polytechnic Institute, a Master in Business Administration from The University of Texas in Austin, and was a Captain in the United States Air Force.
Job Titles:
- Member of the Board of Directors
- Executive Director Product Integrity, Merck & Co.
Tony serves as Merck's Executive Director of Product Integrity, with responsibility for the development and execution of the Company's strategy that protects Merck products from illicit actions, including counterfeiting, diversion, tampering, and theft. His work focuses on securing the supply chain, investigation and enforcement of illicit activity, and building stakeholder awareness to this growing threat to public safety. He is particularly interested in investigations and forensic analysis of counterfeit medicines, applications of advanced intelligence analytics to support these investigations, and collaborative relationships with regulatory and enforcement agencies who can best mitigate risks to patients.
Job Titles:
- Senior Director, Operations Quality and Audits
Ben oversees Rx-360 Joint Audit Program® and Quality departments. He also focuses on membership collaborations to drive the continued success of the Rx-360 Joint Audit Program®. He can be reached at bmills@rx-360.
Job Titles:
- Member of the Board of Directors
- Senior Director of Quality for Procurement
- Senior Director, Quality Assurance - GQAAC, Eli Lilly and Co.
William is currently the Senior Director of Quality for Procurement and Operations for Eli Lilly and Company. He has worked in the pharmaceutical industry for nearly 20 years and holds a B.S. in Biology from Purdue University. Since joining Lilly, William has held roles in manufacturing quality, global auditing, compliance, and external manufacturing. He is recognized as an expert in supplier and material management.
With nearly 50 years of experience, Brian has a wealth of knowledge and embodies professionalism, accuracy, and speed. His innate ability to listen is reflective of Brian's attention to detail, as well as his unflinching propensity for analyzing a situation and responding in a clear, concise, and anticipatory manner. At Rx-360, Brian is responsible for helping to manage our licensable audit reports. He can be reached at bshipley@rx-360.org.
Christian Liebl started at Schreiner MediPharm's global headquarters, close to Munich/Germany, as a Product Manager in 2009. In 2011, he relocated to their new U.S. facilities in Blauvelt, NY, to establish and lead the U.S. Product Management and Development Department.
After working as the Project Manager reporting to the CEO of the largest ready-mix concrete company in Europe for 1.5 years, Christian re-joined Schreiner in 2018. He was then promoted to his current role in the Innovations and Business Development Group. As Senior Innovations and Process Manager, he works closely with key customers to solve unique challenges and identify their future needs.
Christian holds a degree in Business Engineering from the University of Applied Sciences in Würzburg/Schweinfurt (Germany). In 2021, he received his Executive MBA with honors from Quantic School of Business and Technology in Washington, D.C.
Job Titles:
- Member of the Board of Directors
- Director, Corporate Quality Audits and Compliance, Biogen
Job Titles:
- Manager, Audit Scheduling and Execution
Crystal is responsible for helping to schedule and execute audits. She can be reached at cwong@rx-360.org.
Diana is responsible for helping to manage our licensable audit reports. She can be reached at ddasilva@rx-360.org.
Job Titles:
- Member of the Board of Directors
- Head of Quality Management System BPS, Sartorius
Job Titles:
- Director of the U.S. Food & Drug Administration 's Center for Drug Evaluation & Research
Job Titles:
- Director of Quality ( Joint Audit Program )
With nearly 20 years of experience in the pharmaceutical industry, Jaye is an integral part of Rx-360's leadership team. Understanding first-hand the challenges of hosting audits, she appreciates the consortium's ability to reduce the audit burden for suppliers and manufacturers and she feels real satisfaction helping the industry in this way. More robust and refined than ever, the Rx-360 Credit Program is something that motivates Jaye because it is a great example of how the consortium stimulates reciprocity for members. Jaye's team of dedicated audit and quality personnel make a significant impact for Rx-360 every day, and she is inspired working alongside them. Analytical, strategic, and dependable, Jaye continues to make an indelible mark on Rx-360 and all who participate in its programs. Jaye can be reached at jgreene@rx-360.org.
Job Titles:
- Member of the Board of Directors
- Director Quality, Avantor
After receiving her degree in biology, Jennifer started her career manufacturing vaccines for a small start-up which was soon acquired by Baxter. In her ten years at Baxter, she served in many roles, including a small stint in process development, and finally in quality.
Jennifer then spent some time with the FDA working on compliance cases including warning letters and consent decrees. She was involved in the Ben Venue consent decree and the Johnson and Johnson phantom recall, consent decree and government oversight committee meetings. After leaving the FDA, she worked with Sanofi as their Head of Audits, Americas, but spent most of her time in the Sanofi vaccine facilities in France and Canada, helping to alleviate a warning letter and then in Germany helping with the launch of several combination products.
Immediately prior to joining PTC, Jennifer was the VP of Quality for the biologics business unit for Patheon, now ThermoFisher. She was responsible for manufacturing sites in Australia, Europe and the US, manufacturing phase I to commercial products. Jennifer has also completed an MBA from the University of Maryland.
Jim Fries has a long history of success in the medical device, diagnostic, and life science industries, helping grow and lead organizations such as VNUS Medical, LipoScience, Vascular insights, OrthoForge, and Novasys Medical. Jim has also been a delegate to the World Health Organization as well as part of many FDA Pathway Teams, and Clinical Guideline Committees.
Jim received his B.A in Organizational Behavior and his MBA from Eastern University in St. David's, PA. He resides in suburban Philadelphia with his wife and three children. Jim truly has a personal mission to enhance the world of patient safety and is dedicated to serving Rx-360 and its membership.
Job Titles:
- Member of the Board of Directors
- Global Head of Quality - Bioscience, Lonza
Job Titles:
- Treasurer
- Head of Quality Management Systems
Kathleen Silva is the Head of Quality Management Systems and Audits. In this role she is responsible for overseeing the global Life Science framework for compliance with Quality, Regulatory and Industry standards. This is accomplished through regular internal audits of our Life Science sites along with global Life Science Standards and Procedures.
Previously, Kate held the role of Head of Quality, Biologics for Merck Millipore. In this role she was the cluster lead for quality activities in connection with the respective Business and Operations Units. She provided oversight and governance to ensure quality of products, services and suppliers in compliance with external regulations and customer quality requirements
Kate Joined Merck Millipore in July 2010. Before that she worked for AMAG Pharmaceuticals responsible for overall Quality Control and Compliance. She has previously worked for Vertex Pharmaceuticals supporting commercial quality control and held several management positions in quality and research for 3M Medical, Pharmaceutical and Microbiology divisions. She is an experienced leader in all areas of Quality and has broad experience in cGxP and FDA/EU regulations.
Kate received a Doctorate of Philosophy (Ph.D.) in Analytical Chemistry from the University of Minnesota and a Bachelor of Science in Chemistry (ASC) with a minor in Microbiology from the University of Wisconsin-La Crosse.
Job Titles:
- Senior Manager, Member Development
- Senior Manager, Membership Development
Job Titles:
- Finance
- Senior Director
- Finance - Related Inquiries
- Member of Rx - 360
Kristen is an integral member of Rx-360's leadership team, overseeing all consortium finances. She also works closely with the CEO, Board Chair, and Board Treasurer on pertinent financial matters, including membership engagement and Joint Audit Program® growth. She can be reached at kfarr@rx-360.org.
Job Titles:
- Member of the Board of Directors
- SVP Quality & Regulatory, Hovione
Job Titles:
- Coordinator, Audit Scheduling & Execution
Job Titles:
- Member of the Board of Directors
- Director, Global Supplier Quality and Compliance, Curia
Renee is responsible for helping to manage our licensable audit reports.
Job Titles:
- Chairman Emeritus
- VP in Avantor 's Biopharma Production
Rob Welsh is VP in Avantor's Biopharma Production business., He is responsible for leading a cross-functional effort to enhance Avantor's product and service solutions in response to evolving biopharmaceutical customer and market needs. Efforts are largely focused in the areas of risk mitigation, process efficiencies, and assurance of supply. Rob is an active Rx-360 volunteer serving on the Board of Directors for the past 5+ years. Prior to becoming a board member, he served as chair on the Supply Chain Security steering committee and as Co-Chair of the Upstream to manufacture work group where he co-authored 2 white papers on upstream to manufacture supply chain security, and has presented on behalf of Rx-360 at several industry conferences.
Job Titles:
- Member of the Board of Directors
- Hub Head, NALA Supplier Quality Audit & Compliance Pharma Supply Chain, GSK
Scott Kammer is responsible for leading Global Product Protection for Takeda Pharmaceuticals. Scott provides 25 years corporate security experience in the pharmaceutical industry, working for Abbott Laboratories and Takeda Pharmaceuticals. He has been instrumental in the development and implementation of a global strategy to combat illicit trade using a multi-prong approach. This multi-prong approach involves enforcement, product protection technologies, forensics, supply chain security and education.
Scott serves on the Rx-360 Board where he has provided external training on supply chain security to regulators, customs and industry. In addition, he has served on the APEC Life Sciences Innovation Forum as a technical advisor on supply chain security and spoke at numerous engagements.
Previously Scott had extensive experience in conducting complex international investigations that have led to successful prosecution and has built strong relations to monitor and detect illicit trade within the global supply chain.
Job Titles:
- Member of the Board of Directors
- Head of Quality Audits & Inspections, Bayer
Tom is a 25 year veteran of the pharmaceutical industry having served in various positions of increasing responsibility within Production and Quality Assurance.